Black Reinforced Intelligent Reload, For use with Signia stapling system


Product Overview

Black Reinforced Intelligent Reload, For use with Signia stapling system
Tri-Staple 2.0 - SIGTRSB45AXT


Device Description

A unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.


Environmental Conditions

  • Handling Environment Atmospheric Pressure - KiloPascal
    • 101.00
    • 55.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • N/A
  • Handling Environment Temperature - Degrees Fahrenheit
    • 104.00
    • -29.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 94.00
    • 63.00

  • Device Sizes

  • Length: 45 Millimeter
  • Extra/Thick;
    • Length: 45 Millimeter
    • Extra/Thick;


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GDW

    Device Name: Staple, Implantable

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: SU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 878.4750

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 20884521717616

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521717619

    Package Quantity: 6

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: PACK_OR_INNER_PACK


    Device Id: 10884521717619

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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